A Study of Subcutaneous HUMIRA (Adalimumab) Injection to Assess Adverse Events and Change in Disease Activity In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)

AbbVie

Status: Completed

Conditions: Crohn's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT05394805

P20-043

Details and patient eligibility

About

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective Humira (adalimumab) is in treating moderately to severely active CD in China. Adverse events and change in disease activity will be assessed.

Humira (adalimumab) is a drug approved for the treatment of Crohn's disease (CD).All study participants will receive Humira as prescribed by their study doctor in accordance with approved local label. Approximately 252 participants will be enrolled in China.

Participants will receive subcutaneous HUMIRA (adalimumab) injection as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for 1 year.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants meet the diagnosis of moderate to severe Crohn's disease.
• Participants prescribed with Humira, under investigators' sufficient consideration of benefits/ risks per local label.

Exclusion criteria

• Participants who have any of the contraindications as per adalimumab (Humira) label in China.
• Participants who are allergic to any component of adalimumab (Humira).
• Participants with active hepatitis B diagnosed.
• Participants with severe active infection, or known history of active or latent tuberculosis (TB), or latent TB infection with inadequate treatment.
• Participants with cancer diagnosed, excluding also those with non-melanoma skin cancer (NMSC) completely treated, per local label.
• Participants with moderate to severe heart failure.
• Participants who are unwilling to participate, or not suitable for participation as judged by the investigator at risk of noncompliance to study procedure.
• Participants who are enrolled to other interventional studies.
• Participants who are prescribed with adalimumab but choose Humira bio-similar in China.

Trial design

156 participants in 1 patient group

Participants treated with Humira (Adalimumab)

Description:

Participants prescribed Humira (adalimumab) for moderately to severely active crohn's disease (CD) in routine clinical practice.